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Fructose and Lactose Intolerance and Malabsorption in Functional Gastrointestinal Disorders

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
C. Wilder-Smith, Brain-Gut Research Group Identifier:
First received: March 10, 2014
Last updated: July 27, 2015
Last verified: July 2015

Background: The association of fructose and lactose intolerance and malabsorption with the symptoms of different functional gastrointestinal disorders (FGID) is unclear. The mechanisms behind the multi-organ symptoms remain unclear. Both FGID and saccharide intolerances are common (>10% of any given population). Dietary modification based on intolerance diagnostics could provide an effective treatment for FGID, which are otherwise difficult to treat.

Aim: To investigate the prevalence and interrelationships of fructose and lactose intolerance (symptom induction) and malabsorption (breath test gas production) and their association with clinical GI as well as non-GI symptoms in FGID and the outcome of standard dietary intervention. Mechanisms related to symptom genesis will be investigated using metabolomic analysis of plasma and urine by gas chromatography/time-of-flight mass spectrometry (GC/TOFMS).

Methods: Fructose and lactose intolerance (defined by positive symptom index) and malabsorption (defined by increased hydrogen/methane) will be determined in successive male and female FGID patients in a single center using breath-testing. Symptoms will be recorded using standardised questionnaires and the Rome III criteria. The prevalence of the intolerances in the different FGID subgroups and the associations between breath testing results, clinical symptoms and the outcome of dietary modification will be assessed. Factors predictive of the outcome of dietary modulation will be screened for. GC/TOFMS will be used to assess the human and microbial metabolome in urine and plasma.

Condition Intervention
Functional Gastrointestinal Disorders
Lactose Intolerance
Fructose Intolerance
Other: no intervention: observational study

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Fructose and Lactose Intolerance and Malabsorption: the Relationship Between Metabolism and Symptoms in Functional Gastrointestinal Disorders

Resource links provided by NLM:

Further study details as provided by Brain-Gut Research Group:

Primary Outcome Measures:
  • Number with adequate symptom relief [ Time Frame: 6-12 weeks ]
    adequate symptom relief in response to reduction of fermentable sugars

Secondary Outcome Measures:
  • Association between adequate symptom relief and test variables [ Time Frame: 6-12 weeks ]
    association between demographic, breath test and metabolomic factors and adequate relief due to dietary modification

Biospecimen Retention:   Samples Without DNA
blood, urine and stool

Estimated Enrollment: 3000
Study Start Date: March 2014
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
food intolerance
lactose intolerance fructose intolerance neither intolerance
Other: no intervention: observational study


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Successive patients referred to our gastroenterology practice with functional GI disorders according to ROME 3 criteria.

Inclusion criteria:

  • Patients with functional GI disorders according to ROME 3 criteria
  • Without evidence of organic disease by standardised testing in GI practice.

Exclusion criteria:

  • Current or relevant history of organic disease.
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Please refer to this study by its identifier: NCT02085889

Gastoenterology Group Practice
Bern, Switzerland
Sponsors and Collaborators
Brain-Gut Research Group
Principal Investigator: Clive Wilder-Smith, MD Brain-Gut Research Group
  More Information

Responsible Party: C. Wilder-Smith, Principle Investigator, Brain-Gut Research Group Identifier: NCT02085889     History of Changes
Other Study ID Numbers: BGRG-2415b
Study First Received: March 10, 2014
Last Updated: July 27, 2015

Additional relevant MeSH terms:
Lactose Intolerance
Digestive System Diseases
Gastrointestinal Diseases
Malabsorption Syndromes
Fructose Intolerance
Pathologic Processes
Intestinal Diseases
Carbohydrate Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Fructose Metabolism, Inborn Errors processed this record on March 28, 2017